A care facility may receive requests for a preparation for a therapy that is to be administered to a patient. As such, the patient care facility may prepare preparations corresponding to the requested therapy for administration to a patient. In conjunction with the compounding, the patient care facility may determine an amount for one or more ingredients for the preparation (e.g., as a precursor to compounding an order or prescription) which typically has been determined by a physician singularly or in conjunction with a dietician, pharmacist or other care provider. A pharmacy of the patient care facility may also be tasked with compounding the preparations corresponding to the requested therapy for administration to the patient.
Accordingly, the pharmacy may be required to compound large numbers of, for example, IV nutritional formulations also referred to as parenteral nutrition or PN, on a daily basis, which may be challenging. For example, due to injury, disease, or trauma, a patient may need to receive all or some of their nutritional requirements intravenously. In this situation, the patient may receive a parenteral nutritional formulation which, for example, may contain one or more of the following types of chemical ingredients: amino acids, dextrose or carbohydrate, lipid emulsions, vitamins, minerals, electrolytes, etc. Accordingly, there may be a large number of different ingredients or compounds in a typical large-volume parenteral, such as a Total Parenteral Nutrition (TPN) parenteral formulation in which perhaps 30 or more individual ingredients or components may be used.
In this regard, ready to use, pre-packaged, premix formulations (e.g., sometimes in single, double, triple, etc., chamber containers) have been proposed to provide a convenient alternative to compounding all of the potentially many ingredients or compounds in a given preparation. For example, a well-known two chamber bag product containing a solution comprising dextrose or carbohydrate in one chamber and amino acids in a separate second chamber is sold under the trademark CLINIMIX® and CLINIMIX® E (Baxter Healthcare Corporation, Deerfield, Ill.). CLINIMIX products have advanced the field of large-volume parenteral treatment by providing a wide range of physically stable, “ready-to-use”, IV nutrition admixtures manufactured under sterile, high quality conditions. CLINIMIX solutions are indicated as a caloric component in a parenteral nutrition regimen and as the protein (nitrogen) source for offsetting nitrogen loss or for treatment of negative nitrogen balance in patients where: (1) the alimentary tract cannot or should not be used, (2) gastrointestinal absorption of nutrients is impaired, or (3) metabolic requirements for protein are substantially increased, as with extensive burns. FIGS. 1A and 1B respectfully illustrate the composition of various CLINIMIX and CLINIMIX E solutions.
Another well known commercially available ready to use parenteral formulation is OLIMEL™ (Amino Acids, Dextrose and Lipids, with/without Electrolytes) emulsion for infusion, sold by Baxter Healthcare Corporation. OLIMEL is marketed in a triple-chamber bag for parenteral nutrition (PN) and provides adult patients with the essential ingredients of balanced nutrition: protein, carbohydrates and lipids (fats), in a single container, simplifying the preparation of PN for hospitalized patients. The range of OLIMEL formulations, with various concentrations of protein and carbohydrates and an olive oil and soy based lipid emulsion, address the needs of specific patient groups, such as the critically ill, surgery patients and the chronically ill.
OLIMEL is available in multiple formulations, offering one of the highest protein concentration in a multichamber bag and formulations that provide a proportionate amount of glucose. OLIMEL is unique in that it contains a lipid in the form of an olive oil and soy based IV fat emulsion, Baxter's proprietary CLINOLEIC. The European Society of Clinical Nutrition and Metabolism (ESPEN) guidelines stress the need to adjust protein and energy formulas based on patients' requirements, as is offered in the OLIMEL formulations. For example, patients who have undergone trauma (such as surgery) experience a breakdown in muscle mass to support healing, so they need protein to help replace the lost muscle mass. Hospitalized patients also need energy supplied by carbohydrates, but supplying too much can lead to hyperglycemia (excessive sugar in the blood), and can impact clinical outcomes. The OLIMEL family of products enables clinicians to match the nutritional therapy to the patient, through a premixed bag that requires fewer steps from preparation to administration.
NUMETA™ was introduced by Baxter Healthcare Corporation at the 22nd Annual European Society of Pediatric and Neonatal Intensive Care (ESPNIC) Medical and Nursing Annual Congress in Hanover. Germany, as the first and only triple-chamber system with formulations specifically designed to meet the range of intravenous (IV) nutritional requirements of neonatal and pediatric patients (preterm newborns through age 18). This premix therapy addresses an important unmet medical need to support neonatal and pediatric patients' changing daily nutritional needs with ready-to-use IV nutrition.
Many preterm infants rely on IV nutrition, also known as parenteral nutrition (PN), at birth to meet all or part of their daily nutritional requirements. Unlike adults, children have a need for growth, which puts them at a particularly high risk of malnutrition because of higher nutritional demands. Acute malnutrition affects almost 25 percent of children admitted to local hospitals, with consequences that include impaired tissue function, suppressed immune systems, defective muscle function and reduced respiratory and cardiac reserve (or capacity).
This ready-to-use nutrition system provides neonatal and pediatric patients with a balanced formulation of amino acids (protein), glucose (carbohydrates), lipids (fats) and electrolytes in a triple-chamber container. NUMETA is designed according to the European Society for Pediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN)-European Society for Clinical Nutrition and Metabolism (ESPEN) Guidelines for Pediatric Parenteral Nutrition to provide well-balanced nutrition that supports the growth of a majority of neonatal and pediatric patients. The ingredients are provided in separate compartments and can be mixed and administered at the point of care, reducing the possible risk of medication errors and contamination, while simplifying the prescription and delivery of parenteral nutrition. Parenteral nutrition formulations can be complex, involving numerous calculations, multiple ingredients, additive dosages and administration rates. In this regard, bags of premix formulations may be a practical option for hospitals to provide standard premix PN for patients in a convenient and easy-to-activate system. The nutritional components are stored in different sections or chambers of a bag, separated by special seals. A clinician breaks the seal between the chambers and gently mixes the admixture or solutions. With multichamber bag technology, fewer steps from preparation to administration may reduce the opportunities for error and the potential for touch contamination of the contents. In this regard, the A.S.P.E.N. guidelines support the use of standard formulations to help facilitate a standard process that reduces variation and promotes uniformity among clinicians and healthcare facilities.
Notwithstanding the benefits of premix PN formulations, and despite the fact that they are available in multiple formulations, clinicians may still desire the ability to customize individual patient prescriptions. For example, maintenance vitamins, additional electrolytes and trace elements may not be included, or they may not be present in the desired amounts. Therefore, there is a need to be able to compound ingredients, additives, and/or compounds into premix PN formulations. Methods for reliably determining amounts of an additive or ingredient additions to preparations that utilize premix parenteral solutions are therefore needed. Furthermore, after addition there may be a need to ensure that the labeling of such solutions is accurate and efficacious for that customized patient dosage form. Presently, such additions may be determined using hand calculations, and other methods that are prone to error, particularly in the treatment setting, such as at a hospital, where such calculations may be made by fatigued staff. For instance, simple computational error in such compounding with premix parenteral solutions with additions can lead to preparations with mistakes that in turn may lead to incorrectly prepared and/or mislabeled parenteral solutions and the possibility of risk to the patient. Furthermore, manual compounding of preparations by human users that include premix solutions may introduce the potential for additional errors and/or contamination of the preparation.